Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children

Phase 1

Completed

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT01613573
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);be in preadolescence (Tanner stage 1) and have a CA >3 years;have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV; receive no prior GH treatment or stop the GH treatment for more than 4 weeks;sign informed consent

Exclusion Criteria

• Patients with Liver and kidney dysfunction (ALT> upper limit of normal 2 times, Cr> upper limit of normal), hepatitis B virus detection, antigen-HBc, HBsAg and HBeAg are positive
• patients with known to a highly allergic constitution or allergic to the drug of this study
• Patients with diabetes, serious cardiopulmonary, blood system, malignant tumor and other diseases or systemic infection in immunocompromised and mental diseases
• Patients with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, Laron syndrome, GH receptor deficiency, girls with growth delay have not ruled out chromosomal abnormalities
• Participated in clinical trials of other drugs in 3 months
• Other cases that the researchers considered unsuitable for this clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
pharmacokinetics parameter	Somatropin AQ: predose(0),1,2,3,4,6,8,10,12,16,20,24 hours post-dose. PEG somatropin: predose (0),2,4,8,12,18,24,36,48,72,96,120,144,168 hours post-dose	Cmax, AUC during the time interval for the first dose and last dose, Half-Life(t1/2), Apparent body clearance(CL), Mean residence time(MRT),steady-state volume of distribution(Vss)

Secondary Outcome Measures

Name	Time	Method
IGF-1, IGFBP-3	Day I to Day 7 in each treatment period (33 time points) for daily used somatropin, Day I to Day 42 in each treatment period (35 time points) for PEG somatropin